510(k) Report

510(k) · Cleared

Cleared

XPress BCD Breast Compression Device

K163388510(k) TraditionalCleared Jul 19, 2017229-day reviewClass II21 CFR 892.1710

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Xpress Bcd, LLC · POY Post Breast Biopsy Hemostatic Breast Compression Device

Cleared on Jul 19, 2017 as substantially equivalent to K113607 (Giotto USA, LLC, 2012) after a 229-day review. Its family tree reaches back 4 generations to 1992.

Decided
Jul 19, 2017
Review
229 days
Class
Class II
Product code
POY
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K923061 (1992). No later device cites it as a predicate yet.

K923061 · Mammoscan · Fischer Imaging Corp. · 1992K990192 · Biopsy-Digit · Sitco, Inc. · 1999K062039 · Biopsy Digit-AM · Giotto USA, LLC · 2006K113607 · Biopsy Digit S Biopsy SL · Giotto USA, LLC · 2012199019952000200520102015
K113607 · Biopsy Digit S Biopsy SL · Giotto USA, LLC · 2012K062039 · Biopsy Digit-AM · Giotto USA, LLC · 2006K990192 · Biopsy-Digit · Sitco, Inc. · 1999K923061 · Mammoscan · Fischer Imaging Corp. · 19920
  1. Root · 4 generations backK923061 MammoscanFischer Imaging Corp. · 1992
  2. 3 generations backK990192 Biopsy-DigitSitco, Inc. · 1999
  3. 2 generations backK062039 Biopsy Digit-AMGiotto USA, LLC · 2006
  4. 1 generation backK113607 Biopsy Digit S Biopsy SLGiotto USA, LLC · 2012
  5. This deviceK163388 XPress BCD Breast Compression DeviceXpress Bcd, LLC · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K923061MammoscanFischer Imaging Corp.1992—
−3K990192Biopsy-DigitSitco, Inc.1999—
−2K062039Biopsy Digit-AMGiotto USA, LLC2006—
−1K113607Biopsy Digit S Biopsy SLGiotto USA, LLC2012—
0 (this device)K163388XPress BCD Breast Compression DeviceXpress Bcd, LLC2017—
FIG. 1 — Lineage of K163388, 1992–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K113607Biopsy Digit S Biopsy SL
Summary page 4
…de: POY Regulation Number: 892.1710 Classification Panel: Radiology 4.0 PREDICATE DEVICE Device Trade Name: Biopsy Digit S and Biopsy Digit SL 510(k) Control Number: K113607 Product Code: IZH Manufacturer: Giotto USA, LLC, Wichita, KS 5.0 INDICATIONS FOR USE The Xpress BCD is a reusable device indi…
Giotto USA, LLC2012—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
  • None of the 4 ancestors has a recall.

How does its category compare?

All POY devices

POY Post Breast Biopsy Hemostatic Breast Compression Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · POY

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · POY

Too few POY 510(k)s in any year since 2007 to give a median.

Recalls per year · POY

No recall names POY since 2007.

Adverse event reports per year · POY

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code POY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20171—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Xpress BCD is a reusable device indicated for use with stereotactic biopsy platforms to apply temporary focal mechanical compression to a stereotactic breast biopsy site to achieve hemostasis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K163388 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163388: XPress BCD Breast Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163388

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026